With this approval, SEZABY becomes the first and only product specifically indicated in the
SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection. It was granted orphan drug designation by the
SEZABY was recently licensed by SPARC to Sun Pharma. Under the terms of the license agreement, SPARC is eligible to receive a milestone payment on approval of SEZABY by the
SEZABY is an exciting addition to our growing portfolio of specialty branded products in the
For years, physicians have had limited treatment options to manage neonates with seizures. SPARC is proud to have developed benzyl alcohol-free and propylene glycol-free phenobarbital sodium powder for injection as the first treatment option now approved by the
SEZABY was approved based on the results of NEOLEV2, a phase 2 study that evaluated levetiracetam compared to phenobarbital in the first-line treatment of neonatal seizures.
About Neonatal Seizures
Seizures are more common in the neonatal period (first 28 days of life) than at any other time during life. The incidence of seizures during the first month of life is approximately 1 to 4 per thousand babies.1 Their occurrence is associated with poor outcomes such as cerebral palsy, global developmental delay, and epilepsy in up to 40 to 60% of babies who suffer seizures.2
About the NEOLEV2 Trial
Phenobarbital has been commonly used to treat neonatal seizures. NEOLEV2 was a phase 2 study that evaluated levetiracetam compared to phenobarbital in the first-line treatment of neonatal seizures. The randomized controlled trial compared the incidence of recurrent seizures in neonates treated with phenobarbital vs. levetiracetam in 94 neonates. Twenty-four hours following the administration of phenobarbital or levetiracetam, 73% vs. 25% were seizure-free in the respective groups.
The most common adverse reactions (incidence > 5% patients overall) were abnormal respiration, sedation, feeding disorder, and hypotension.
About SEZABY (phenobarbital sodium powder for injection)
SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection. It was granted orphan drug designation by the
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